Based on research that showed Erbitux® (cetuximab) improved survival compared to best supportive care in patients with advanced colorectal cancer who had already had their cancer get worse with standard chemotherapy treatments, the Food and Drug Administration has approved a change in Erbitux labeling. The label will now reflect improved survival when Erbitux is used alone to treat patients after failure of irinotecan and oxaliplatin regimens.

In that study. 572 patients were randomly assigned either to receive cetuximab by IV every week or to have best quality supportive care. Supportive care was designed to reduce symptoms but not directly treat tumors. All patients had previously been treated with chemotherapy regimens that included irinotecan and oxaliplatin, as well as 5FU or capecitabine.

There was also an improvement in the time before the cancer began to progress with cetuximab. Nineteen patients (6.6 percent) had their tumors shrink partially with cetuximab, but none had a similar response with supportive care.

Serious side effects that were more frequent in the cetuximab group included rash, infection, confusion, pain, and low magnesium levels. Twelve percent of patients had a severe (grade 3) rash.